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¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer
Sponsor: The University of Hong Kong
Summary
Multiparametric magnetic resonance imaging (mpMRI) is the standard imaging modality for prostate cancer diagnosis and focal therapy planning. However, 10-20% of clinically significant prostate cancers (csPCa) are not visible on mpMRI (PI-RADS 1-2). These MRI-invisible lesions, typically identified only on systematic biopsy, are currently not targetable by MRI-guided focal therapy, leaving patients with the choice between whole-gland radical treatment or active surveillance. This prospective, multi-centre, single-arm phase II trial investigates whether pelvis-only ¹⁸F-PSMA-1007 positron emission tomography-computed tomography (PET-CT) can identify MRI-invisible csPCa and serve as the therapeutic navigation tool for focal ablation. Men aged ≥50 years with localized, intermediate-risk prostate cancer (ISUP Grade Group 2-3) and at least one MRI-invisible csPCa focus undergo a PET-CT. If a PET-avid lesion corresponds anatomically to the MRI-invisible biopsy-positive site, the patient receives focal therapy using an energy modality (targeted microwave ablation, high-intensity focused ultrasound, or irreversible electroporation) selected based on tumour anatomy, guided by organ-based tracking. The primary endpoint is the absence of csPCa (Grade Group ≥2) on 6-month targeted biopsy of all treated zones. Secondary endpoints include out-of-field recurrence, functional outcomes, and safety. The study requires 45 treated patients (total enrolment \~60) across two Hong Kong centres and will be completed within 3 years.
Official title: Seeing the Unseen: ¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer (The FOCUS-PSMA Study)
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-20
Completion Date
2029-11-30
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Focal Therapy for Prostate Cancer
Focal ablation performed under general or spinal anaesthesia with the patient in the lithotomy position. The ¹⁸F-PSMA-1007 PET-CT DICOM dataset is imported into the Koelis Trinity® platform and fused with real-time transrectal ultrasound using organ-based tracking (OBT). The urologist selects one of the following modalities based on tumour location and anatomical constraints: (1) targeted microwave ablation (TMA) using the TATO3® needle; (2) high-intensity focused ultrasound (HIFU) using the Sonablate® system; or (3) irreversible electroporation (IRE) using the NanoKnife® or PoriNova® systems. Treatment is delivered transperineally with a 5-10 mm margin around the PET-avid MRI-invisible lesion and any concurrent MRI-visible lesions, maintaining a ≥5 mm safety distance from the sphincter, rectum, and neurovascular bundles. Procedural parameters (modality, applicator numbers, treatment times, estimated ablation volumes) are recorded.
Locations (1)
Queen Mary Hospital
Hong Kong, 香港島, Hong Kong